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RecruitingPhase 2

A Study of Selinexor Monotherapy in Subjects With JAK Inhibitor-naïve Myelofibrosis and Moderate Thrombocytopenia

Karyopharm Therapeutics Inc · NCT05980806

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
58
US sites recruiting
7
Study start
April 22, 2024
Record last updated
February 12, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

The main purpose of this study is to evaluate the efficacy of selinexor in JAKi-naïve participants with myelofibrosis (MF) and with normal platelet counts or with mild to moderate thrombocytopenia based on spleen volume reduction (SVR). Additional efficacy and safety parameters will also be assessed during the study.

Being studied: Selinexor 60 mg; Selinexor 40 mg; Ruxolitinib; Pacritinib; Momelotinib

Conditions: Myelofibrosis; Moderate Thrombocytopenia; Mild Thrombocytopenia

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Key Inclusion Criteria

  • A diagnosis of MF or post-ET or post-PV MF according to the 2016 World Health Organization (WHO) classification of MPN, confirmed by the most recent local pathology report
  • Measurable splenomegaly during the screening period as demonstrated by spleen volume of greater than or equal to (>=) 450 cubic square centimeter (cm\^3) by MRI or CT scan (results from MRI or CT imaging performed within 28 days prior to C1D1 are acceptable)
  • DIPSS risk category of intermediate-1 with symptoms, or intermediate-2, or high-risk
  • ECOG Performance Status less than or equal to (\<=) 2
  • Platelet count of greater than or equal to (>=) 50 x 10\^9/L without platelet transfusion within 7 days prior to the first dose of selinexor
  • Absolute neutrophil count (ANC) >=1.0 × 10\^9/L without need for growth factors within 7 days prior to the first dose of selinexor
  • Adequate liver function as defined by the following: aspartate transaminase (AST) and alanine transaminase (ALT) \<= 2.5 × upper limit normal (ULN) and serum total bilirubin \<= 3×ULN
  • Calculated creatinine clearance (CrCl) greater than (>) 15 milliliter per minute (mL/min) based on the Cockcroft and Gault formula
  • Active symptoms of MF as determined by presence of at least 2 symptoms with an average score >= 5 or total score of >= 12 at screening (at least 5 of 7 consecutive days immediately preceding C1D1) using the MFSAF V4.0
  • Must provide bone marrow biopsy samples (samples obtained up to 3 months prior to C1D1 are permitted) at screening and during the study
  • Currently not eligible for stem cell transplantation
  • Must be willing to complete the MFSAF V4.0 daily during the study for evaluating the symptom response (i.e., TSS50)

Key Exclusion Criteria

  • More than 10% blasts in peripheral blood or bone marrow (accelerated or blast phase)
  • Previous treatment with JAK inhibitors for MF
  • Previous treatment with selinexor or other XPO1 inhibitors
  • Females who are pregnant or lactating
  • Prior splenectomy, splenic radiation, or a splenic embolization within 6 months prior to C1D1
  • History of myocardial infarction, unstable angina, percutaneous transluminal coronary angioplasty (PTCA), coronary artery bypass graft (CABG), cerebrovascular accident (transient ischemic attack [TIA]), ventricular arrhythmias, congestive heart failure class > 2 per New York Heart Association (NYHA) within 6 months of C1D1
  • Unable to tolerate two forms of antiemetics prior to each dose for the first two cycles

Recruiting US locations

  • City of Hope - Duarte Main Site

    Duarte, CA 91010

    Site contact: Haris Ali · 6263564673 · harisali@coh.org

  • Maryland Oncology Hematology - Independent of SCRI/ US Oncology

    Columbia, MD 21044

    Site contact: Mohit Narang · 304-942-9220 · mohit.narang@usoncology.com

  • Weill Cornell Medicine NewYork-Presbyterian

    New York, NY 10021

    Site contact: Ellen Ritche · 646-962-4580 · ritchie@med.cornell.edu

  • Duke University

    Durham, NC 27705

    Site contact: Lindsay Rein · 919-684-8964 · lindsay.magura@duke.edu

  • Cleveland Clinic

    Cleveland, OH 44195

    Site contact: Aaron Gerds · 216-445-9840 · gerdsa@ccf.org

  • MD Anderson

    Houston, TX 77030

    Site contact: Prithviraj Bose · (713) 792-7747 · PBose@mdanderson.org

  • Huntsman Cancer Institute

    Salt Lake City, UT 84112

    Site contact: Srinivas Tantravahi · 801-213-6170 · Srinivas.Tantravahi@hci.utah.edu

Study contacts (from the official record)

  • Karyopharm Medical Information · (888) 209-9326 · clinicaltrials@karyopharm.com
A Study of Selinexor Monotherapy in Subjects With JAK… (NCT05980806) | Bored Studies